Limitations of the MANOVA of statistical moments in bioequivalence trials of drugs with slow elimination rate: A study with spironolactone

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Abstract
The capacity of the statistical moments for detecting bioavailability changes in bioequivalence studies of drugs with high disposition mean residence time (MRT) is analysed. Two bioavailability trials were carried out with spironolactone in which extent and rate of absorption were modified in a controlled way. The statistical analysis employed was a two‐way MANOVA of statistical moments of the urinary excretion profiles of canrenone. The results indicate a loss in the sensitivity of MRT for detecting changes in absorption rate as drug elimination rate decreases.